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| ID | Type | Description | Link |
|---|---|---|---|
| Parsaclisib | Other Identifier | Incyte Corporation | |
| 2017-000970-12 | EudraCT Number |
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The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1- Closed to Further enrollment | Experimental | Participants who have received prior ibrutinib. |
|
| Cohort 2 | Experimental | Participants who have not received a prior BTK inhibitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Parsaclisib at the protocol-defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Based on Lugano Classification Criteria | ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign 5mm×5mm as default;if no longer visible,0×0mm.Node >5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by >50%in length beyond normal.4.No new lesions. | Up to approximately 161 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Zheng, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
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A total of 110 participants diagnosed with relapsed or refractory marginal zone lymphoma were enrolled into two cohorts based on previous treatment with ibrutinib as Cohort 1: those who were exposed to ibrutinib before enrollment and Cohort 2: those who were not exposed to Bruton's tyrosine kinase (BTK) inhibitor before enrollment. Participants were further allocated to Treatments A and B in each Cohort to receive parsaclisib.
This study enrolled participants at 46 study centers in the United States, Italy, Israel, France, Spain, Poland, Belgium, Great Britain, and Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Treatment A (Exposed to Ibrutinib) | Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 23, 2019 | Jan 14, 2022 |
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| Up to 1305 days |
| Complete Response Rate (CRR) Based on Lugano Classification Criteria | CRR is defined as the percentage of participants with a CR as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. | Up to 1305 days |
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. | Up to 1305 days |
| Overall Survival (OS) | OS is defined as the time from the date of the first dose of study treatment until death from any cause. | Up to 2354 days |
| Best Percent Change From Baseline in Target Lesion Size | Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement. | Up to 1305 days |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention. | From first dose of study drug up to 1980 days |
| Arizona Oncology Associates |
| Tempe |
| Arizona |
| 85284 |
| United States |
| Torrance Health Association | Redondo Beach | California | 90277 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Central Coast Medical Oncology | Santa Maria | California | 93454 | United States |
| UCLA Healthcare Hematology-Oncology | Santa Monica | California | 90404 | United States |
| St. Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| Innovative Clinical Research Institute | Whittier | California | 90603 | United States |
| Loyola University Medical Center | Whittier | California | 90603 | United States |
| Valley View Hospital | Glenwood Springs | Colorado | 81601 | United States |
| St. Mary'S Hospital Regional Cancer Center | Grand Junction | Colorado | 81501 | United States |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Advanced Pharma Cr | Miami | Florida | 33147 | United States |
| Boca Raton Clinical Research Medical Inc. | Plantation | Florida | 33322 | United States |
| Asclepes Research Centers | Weeki Wachee | Florida | 34607 | United States |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center - Consultants in Hematology | Chicago | Illinois | 60612 | United States |
| Clinical Trials of Swla Llc | Lake Charles | Louisiana | 70601 | United States |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Saint Luke'S Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN | Las Vegas | Nevada | 89169 | United States |
| Clinical Research Alliance | New Hyde Park | New York | 11042 | United States |
| Nyu Cancer Institute | New York | New York | 10016 | United States |
| Hematology Oncology Associates of Rockland | Nyack | New York | 10960 | United States |
| White Plains Hospital | White Plains | New York | 10601 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Charleston Hematology Oncology Associates Pa | Charleston | South Carolina | 29414 | United States |
| Renovatio Clinical | The Woodlands | Texas | 77380 | United States |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Aou Maggiore Della Carita | Rosario | S2000KZE | Argentina |
| Icon Cancer Care | Auchenflower | Queensland | 04066 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 05000 | Australia |
| Calvary North Adelaide Hospital | North Adelaide | South Australia | 05006 | Australia |
| Cliniques Universitaires Ucl Saint-Luc | Brussels | 01200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitaire Ziekenhuis Leuven - Gasthuisberg | Leuven | 03000 | Belgium |
| Aalborg University Hospital | Aalborg | 09000 | Denmark |
| Zealand University Hospital | Roskilde | 04000 | Denmark |
| Avicenne Hospital | Bobigny | 93000 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94010 | France |
| Chu Limoges - Hospital Le Cluzeau | Limoges | 87042 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| H�Pital Universitaire Piti�-Salp�Tri�Re | Paris | 75013 | France |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institute Gustave Roussy (Igr) | Villejuif | 94800 | France |
| Universit�Tsklinikum Essen | Essen | 45147 | Germany |
| Universitatsmedizin Gottingen | Göttingen | 37075 | Germany |
| Universit�Tsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Klinikum Ludwigshafen | Ludwigshafen | 67063 | Germany |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Mainz | 55131 | Germany |
| Universit�Tsklinikum Ulm | Ulm | 89081 | Germany |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Hadassah Hebrew University Medical Center Ein Karem Hadassah | Jerusalem | 91120 | Israel |
| Rabin Medical Center - Beilinson Hospital | Petah Tikva | 4841492 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli� | Bologna | 40138 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori | Meldola | 47014 | Italy |
| Fondazione Centro San Raffaele - Milano | Milan | 20132 | Italy |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| Azienda Ospedaliera San Gerardo Di Monza | Monza | 20900 | Italy |
| Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello" | Palermo | 90146 | Italy |
| Presidio Ospedaliero Pescara | Pescara | 65124 | Italy |
| Ospedale Delle Croci - Ematologia Ravenna | Ravenna | 48121 | Italy |
| Sapienza University | Rome | 00161 | Italy |
| Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie | Gdansk | 02-781 | Poland |
| Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci? | Gdansk | 80-952 | Poland |
| Malopolskie Centrum Medyczne S.C. | Krakow | 30-510 | Poland |
| Klinika Transplantacji Komorel Krwiotworczych | Warsaw | 02-776 | Poland |
| Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Hospital General Universitari Vall D Hebron | Barcelona | 08035 | Spain |
| Ico Institut Catala D Oncologia | Barcelona | 08908 | Spain |
| Hgu Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Hm Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Quironsalud Madrid | Madrid | 28223 | Spain |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Kent Oncology Centre - Maidstone Hospital | Maidstone | ME16 9QQ | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| University of Southampton | Southampton | SO16 6YD | United Kingdom |
| Cohort 1: Treatment B (Exposed to Ibrutinib) |
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| FG002 | Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group |
| FG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| COMPLETED |
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| NOT COMPLETED |
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|
Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Treatment A (Exposed to Ibrutinib) | Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| BG001 | Cohort 1: Treatment B (Exposed to Ibrutinib) | Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| BG002 | Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| BG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Based on Lugano Classification Criteria | ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign 5mm×5mm as default;if no longer visible,0×0mm.Node >5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by >50%in length beyond normal.4.No new lesions. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 161 weeks |
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| Secondary | Duration of Response (DOR) | DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 1305 days |
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| Secondary | Complete Response Rate (CRR) Based on Lugano Classification Criteria | CRR is defined as the percentage of participants with a CR as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 1305 days |
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| Secondary | Progression-Free Survival (PFS) | PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Median | 95% Confidence Interval | months | Up to 1305 days |
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| Secondary | Overall Survival (OS) | OS is defined as the time from the date of the first dose of study treatment until death from any cause. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib | Posted | Median | 95% Confidence Interval | months | Up to 2354 days |
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| Secondary | Best Percent Change From Baseline in Target Lesion Size | Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement. | Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. The overall number of participants analyzed is the number of participants with splenomegaly and data available for analysis. | Posted | Mean | Standard Deviation | percent change in lesion size | Up to 1305 days |
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| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention. | Safety Population: all enrolled participants who received at least 1 dose of parsaclisib | Posted | Number | percentage of participants | From first dose of study drug up to 1980 days |
|
up to 2354 days
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Treatment A (Exposed to Ibrutinib) | Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. | 3 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Cohort 1: Treatment B (Exposed to Ibrutinib) | Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. | 2 | 6 | 2 | 6 | 5 | 6 |
| EG002 | Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. | 6 | 28 | 9 | 28 | 25 | 28 |
| EG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. | 25 | 72 | 46 | 72 | 67 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Faecal volume increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperviscosity syndrome | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Marginal zone lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Microangiopathic haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Yersinia infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 27 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2021 | Jan 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656179 | parsaclisib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| OG002 | Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| OG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
|
|
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| OG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
|
|
| OG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
|
|
| OG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
|
|
| OG002 | Cohort 2: Bruton's Tyrosine Kinase Inhibitor Naïve (Treatment A) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| OG003 | Cohort 2: Bruton's Tyrosine Kinase Inhibitor Naïve (Treatment B) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
|
|
| Cohort 1: Treatment B (Exposed to Ibrutinib) |
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. |
| OG002 | Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
| OG003 | Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) | Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. |
|
|